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U.S. and India Planning to Develop Vaccines Through Public-Private Partnerships

With the previous U.S. Secretary of State Hillary Clinton dominating news headlines these days due to her presidential bid, it’s easy to overlook the fact that America has a current Secretary of State hard at work. But some in the pharma industry might have caught a bit of news coming out of India during the final week of August, as Secretary of State John Kerry released a joint statement with his Indian hosts detailing the results of their Strategic and Commercial Dialogue, which included this announcement:

“The Sides further acknowledged that discussions are underway to initiate programs on vaccines for TB, dengue, and respiratory syncytial virus (RSV) with public-private partnerships mode under the U.S.-India Vaccine Action Program.”

The announcement comes at a time when TB continues its unfortunate prevalence in India (there were an estimated 2.2 million cases in 2015), and as dengue, a mosquito-borne viral disease, is on the rise. The World Health Organization (WHO) has reported that cases of dengue in India actually doubled from 2014 to 2015, and in an interview with The Times of India, Dr. Sushila Kataria warned that there would likely be 25% more cases in 2016.

WHO actually approved the first-ever dengue vaccine earlier this year. “Known as Dengvaxia, the vaccine is the product of two decades of research by French-based Sanofi Pasteur,” reported Ted Andersen in Time back in April, adding that there is no established cure for dengue fever and that the complexity of the virus has made it difficult to develop a vaccine. “Another challenge in testing the vaccine has been the need for expensive and time-consuming human trials,” explained Andersen.

Trials have in fact been a sticking point in the approval process for Dengvaxia in India. In a Fierce Pharma article claiming that Sanofi’s struggling dengue vaccine could face competition from India/U.S. alliance, Phil Taylor notes that an expert committee refused to clear Dengvaxia without clinical trials in the local population. This has been a blow to Sanofi, which was expecting far better sales for the vaccine than it has seen so far – €20 million in the first half of the year. “That’s a low return given the $1.5 billion the company spent on developing Dengvaxia,” writes Taylor, especially considering it’s the only product of its type on the market.

A TB vaccine is also an urgent need, as tuberculosis is killing hundreds of people in India every day. The development of an effective new vaccine for TB has eluded researchers for decades, leaving only the Bacillus Calmette-Guerin (BCG) vaccine. Anuradha Mascarenhas writes in The Indian Express that “Standard BCG, while protecting children in most cases against the disease, loses its effectiveness in young people and adults, and has not contributed to reduce the global incidence of TB. Increasing rates of drug-resistant TB now require an effective vaccination strategy.” But, she says, there is hope in the VPM1002 vaccine, developed at the Max Planck Institute for Infection Biology in Berlin, though it is still in trials.

The third disease specified in the joint U.S.-India statement, respiratory syncytial virus (RSV), is lesser known perhaps, but nonetheless widespread and dangerous. In the paper Progress toward a Respiratory Syncytial Virus Vaccine, Kathleen M. Neuzil says that this disease, which mostly affects young children, is responsible for as many as 200,000 deaths each year but does not yet have a vaccine licensed anywhere in the world to counter it. “Such a vaccine has unique challenges, including the young age at peak onset of severe disease and the legacy of vaccine-enhanced illness and death,” she says, but also points out that improvements in vaccine design and a better understanding of the structure of neutralizing RSV antibody are among several reasons that there has been a resurgence in RSV vaccine development, with many important studies now under way.

While there are already vaccines in various stages of research and development for these diseases, their severity and reach demands having “all hands on deck” to fight them. This India-U.S. partnership’s public-private strategy could be the key to moving the process along at a more rapid pace. And the Indo-U.S. Vaccine Action Program (VAP) has already had some success recently, which bodes well: In 2015, India put out its first indigenous vaccine, ROTAVAC, a vaccine against rotavirus which was supported by VAP during its early stages of research. VAP believes ROTAVAC could save the lives of 80,000 children in India each year.

Hopefully the alliance between these two countries can lead to many more lives saved through the development of new vaccines for dengue, TB and RSV.